SBS - The best value in QMS software

Process Monitoring and Measurement - AS9100 Clause 8.2.3

S

sideoiler

#1
OK, we just finished out Re-Cert for Rev C and one of our findings was the fact that we do not show evidence for M&M of all the processes listed in our QAM. I thought this was going to be an issue, so prior to the audit I identified our 6 main processes and informed the auditor that I was focusing on getting all 6 main processes data M&M working effectively 100% before I jumped to the others listed in our Interaction of Process chart. I was informed by the auditor that we were required to show M&M for all processes, and that focusing on the 6 main that were identified does not equal conformance to section 8.2.3. Now as some may know from previous threads, I walked into a 2/3 complete system without any background or knowledge in the ISO/AS requirements / standards, and with that it is taking me some time to research and modify our QMS, striving for compliance to the basic requirements. I'm starting to realize that the previous QA Manager was trying to build a system way more elaborate than needed to be (a lot of extra unnecessary procedures and documents). We are a small job shop with less than 25 employees, where personnel are required to wear multiple hats, and currently there are 24 procedures in our QAM. Trying to get these all in compliance to 8.2.3 with in 30days is going to be a real daunting task...!
My question is, can I re-define our processes and only list the 6 main processes I identified, or am I stuck with the current set of processes listed in our QAM, and now forced to show M&M for all 24... :confused:

Regards
Chris
 
Elsmar Forum Sponsor
#2
Re: Process Monitoring and Measurement AS9100

Hi Chris - seems too much to me. Take it up with your CB's technical management before you do ANYTHING else.
 

Kronos147

Trusted Information Resource
#3
Re: Process Monitoring and Measurement AS9100

My question is, can I re-define our processes and only list the 6 main processes I identified, or am I stuck with the current set of processes listed in our QAM, and now forced to show M&M for all 24... :confused:

Regards
Chris
It's your system. Re-define your 6 processes and move on. The auditor will try to tell you you have more, and that you should assess sub-processes, etc. Remind them (gently) that it is your system, and to show you in AS9100 says there must be a certain number of processes.

In terms of M&M for sub-processes, again, ask them to show you the clear requirement. My recollection is a lot of that stuff is actually in AS9101. I don't know about you, but the cert on my wall says AS9100, not AS9101.

I think Receiving inspection is a main process for us. I can't think of how to measure it. So I have purchasing\receiving inspection as one process and I measure vendor OTD as a M & M. The auditor says he thinks it is a separate process. I told him they are related, and I will not invent something to measure that process, so it is part of a larger process I measure.

The auditor can have his opinion that it should be separate (as do I), but the need for measuring IMHO should be a decision of the organization, not SAE. If keeping the facility clean and safe is a process, how do you measure? Days without an accident? White glove tests?

Busy work..... I don't know about you, but I am not on this planet in the universe to satisfy an auditor with all of their personal baggage and opinions of how to run a business. I know I give this speech each audit about the P & L statement. "AS9100 0.1 The adoption of a QMS... strategic decision made of an organization." I point out that that decision exists in the very front of the standard, and that no other section really talks about the dollars and cents of the business. If an auditor thinks that an AS9100 allows them to assess or audit our financials, I explain to them how absolutely wrong they are. When ever an audit treads on finances, I invite the auditor to justify their actions before proceeding.

I really would like it if SAE concentrated on updating and maintaining their specifications instead of trying to figure out more busy work for Quality departments to do. One example, on page 17 AS9100 Rev. C states "internet sales." "Internet" is a proper noun and needs to be capitalized. How does that mistake go through a committee? Where is their corrective action?

Eric
 
S

sideoiler

#4
Re: Process Monitoring and Measurement AS9100

It's your system. Re-define your 6 processes and move on. The auditor will try to tell you you have more, and that you should assess sub-processes, etc. Remind them (gently) that it is your system, and to show you in AS9100 says there must be a certain number of processes.

In terms of M&M for sub-processes, again, ask them to show you the clear requirement. My recollection is a lot of that stuff is actually in AS9101. I don't know about you, but the cert on my wall says AS9100, not AS9101.

I think Receiving inspection is a main process for us. I can't think of how to measure it. So I have purchasing\receiving inspection as one process and I measure vendor OTD as a M & M. The auditor says he thinks it is a separate process. I told him they are related, and I will not invent something to measure that process, so it is part of a larger process I measure.

The auditor can have his opinion that it should be separate (as do I), but the need for measuring IMHO should be a decision of the organization, not SAE. If keeping the facility clean and safe is a process, how do you measure? Days without an accident? White glove tests?

Busy work..... I don't know about you, but I am not on this planet in the universe to satisfy an auditor with all of their personal baggage and opinions of how to run a business. I know I give this speech each audit about the P & L statement. "AS9100 0.1 The adoption of a QMS... strategic decision made of an organization." I point out that that decision exists in the very front of the standard, and that no other section really talks about the dollars and cents of the business. If an auditor thinks that an AS9100 allows them to assess or audit our financials, I explain to them how absolutely wrong they are. When ever an audit treads on finances, I invite the auditor to justify their actions before proceeding.

I really would like it if SAE concentrated on updating and maintaining their specifications instead of trying to figure out more busy work for Quality departments to do. One example, on page 17 AS9100 Rev. C states "internet sales." "Internet" is a proper noun and needs to be capitalized. How does that mistake go through a committee? Where is their corrective action?

Eric
Thanks for the Info Eric, this helps out a lot...!
 
Thread starter Similar threads Forum Replies Date
W MR Inputs (9.3.2) - "Monitoring and Measurement Results" vs. "Process Performance" Management Review Meetings and related Processes 8
H How to understand "Monitoring the Process"? "Measurement" of the Process? IATF 16949 - Automotive Quality Systems Standard 14
A How to reduce the process SPC monitoring Capability, Accuracy and Stability - Processes, Machines, etc. 3
A How to set up Continuous CpK monitoring of an injection mold process Reliability Analysis - Predictions, Testing and Standards 7
E IATF 16949 Cl. 9.1.2 - Monitoring Process Performance IATF 16949 - Automotive Quality Systems Standard 1
T IATF 16949 Control Plan and Process Monitoring Requirement(s) IATF 16949 - Automotive Quality Systems Standard 1
J Appropriate In-Process Monitoring Frequency for 2X per day Change Set-Up. Statistical Analysis Tools, Techniques and SPC 3
Q Medical Device Manufacturing Process Monitoring Best Practice ISO 13485:2016 - Medical Device Quality Management Systems 2
I Critical Variables Monitoring during Process Validation Qualification and Validation (including 21 CFR Part 11) 4
C Tool Monitoring - Controlling a Process with Better Tool Monitoring Manufacturing and Related Processes 4
H Monitoring the Calibration Process General Measurement Device and Calibration Topics 13
R Minitab for I-MR - Monitoring Process on Temporary Basis & Temporary Limits Using Minitab Software 6
N IQ/OQ for Process Monitoring System - Sensors and HMI System 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 2
C Process Monitoring Instrument Quality Levels or Categorizations General Measurement Device and Calibration Topics 3
F Process Monitoring Gage Calibration Requirements - 7.6.3.2 External laboratory IATF 16949 - Automotive Quality Systems Standard 1
M Temperature/humidity monitoring process procedure Manufacturing and Related Processes 2
T ETO Sterilization - Process monitoring and out-inspection ISO 13485:2016 - Medical Device Quality Management Systems 3
T Monitoring the monitoring process - Customer complaint process isn't being monitored IATF 16949 - Automotive Quality Systems Standard 7
K Process monitoring, measuring and analyzing, does this means all company processes? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
R Process Auditing - Identifying/Monitoring "Key" Processes Sufficient? Process Audits and Layered Process Audits 5
D Corrective and preventive action, process monitoring ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Sharing best practices in customer satisfaction monitoring process Customer and Company Specific Requirements 17
T Process Internal Audit - Requirement on Monitoring Objectives & Improvement ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
C Looking for Process Monitoring /SPC Package - Molded pharma packaging Statistical Analysis Tools, Techniques and SPC 4
S MSA (Attribute Gage R&R) on our process monitoring points Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 2
M Monitoring,measuring... realization process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
A Sample Size and Frequency - In-process monitoring in a mass production shop Statistical Analysis Tools, Techniques and SPC 2
R Gage R&R Studies for Process Monitoring Instruments? Gage R&R (GR&R) and MSA (Measurement Systems Analysis) 4
C Element 4.9.1 Process Monitoring QS-9000 - American Automotive Manufacturers Standard 3
G Process monitoring of portable & stationary oxygen units: Can we use Cpk, Ppk, SPC ? Capability, Accuracy and Stability - Processes, Machines, etc. 3
G Process monitoring - Stationary and portable oxygen units ISO 13485:2016 - Medical Device Quality Management Systems 1
L 4.9.1 Process Monitoring & Operator Instructions QS-9000 - American Automotive Manufacturers Standard 1
A Complaint review as part of the complaint handling process? ISO 13485:2016 - Medical Device Quality Management Systems 3
mustomutlu Process Validation Final Report Other Medical Device and Orthopedic Related Topics 2
Q Process Matrix_Audit Matrix Quality Management System (QMS) Manuals 4
Q Process description for outsourced processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
Q Process matrix examples of ISO 9001 & 14001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
J Need Help with FPY Data in Assembly Process Manufacturing and Related Processes 7
A When someone refuses to follow a process.... Misc. Quality Assurance and Business Systems Related Topics 21
E Software maintenance Process Software maintenance Process to IEC 6204? IEC 62304 - Medical Device Software Life Cycle Processes 3
R AS5553 Clause 3.1.7 f - "Implement a returns process....." AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 5
normhowe "The Problem with Quality Management: Process orientation, controllability and zero-defect processes as modern myths" Book, Video, Blog and Web Site Reviews and Recommendations 2
Judy Abbott General temperature used in the blasting process and laser process Manufacturing and Related Processes 2
B SOP for CNC turret punching machine for sheet metal process Manufacturing and Related Processes 0
A API Monogram audit review process Oil and Gas Industry Standards and Regulations 4
R AS9102 FAI Change in Material / Process Supplier AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
A Process mapping Process Maps, Process Mapping and Turtle Diagrams 1
R MDEL Process Canada Medical Device Regulations 4
optomist1 Rates Daily or Hourly Process Improvement Training Consultants and Consulting 2
S Manufacturing Process FDA FOIA Medical Device and FDA Regulations and Standards News 3

Similar threads

Top Bottom